MedDataX Logo

Adoptive Cell Therapy Plus Chemotherapy and Radiation After Surgery in Treating Patients With Colorectal Cancer

NCT ID: NCT02202928

Last Updated: 2015-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the efficacy of autologous tumor lysate-pulsed dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

60 patients with stageⅠ\~ Ⅲ CRC, who had received surgery and kept their tumor tissue, will be randomly divided into group A (receive DC-CIK treatment, chemotherapy and radiotherapy) or group B (just receive chemotherapy and radiotherapy), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of autologous tumor lysate pulsed DC-CIK cells treatment (every 4 weeks) and 4 cycles chemo-radiotherapy. Patients in group B will receive only 4 cycles chemo-radiotherapy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer Neoplasms Intestinal Neoplasms Digestive System Neoplasms Gastrointestinal Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Colorectal cancer DC-CIK Autologous tumor lysate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chemo-radiotherapy

After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will just regularly follow up.

Group Type SHAM_COMPARATOR

Radiotherapy

Intervention Type RADIATION

45\~50 Gy in 25-28 fractions.

Chemotherapy

Intervention Type DRUG

Oxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks.

DC-CIK

After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will receive 3 cycles of autologous tumor lysate pulsed DC-CIK treatment.

Group Type EXPERIMENTAL

DC-CIK

Intervention Type BIOLOGICAL

8×10\^9 autologous tumor lysate pulsed DC-CIK cells for each infusion, IV (in the vein) for four cycles, each cycle received four infusions with a 1 day interval.

Radiotherapy

Intervention Type RADIATION

45\~50 Gy in 25-28 fractions.

Chemotherapy

Intervention Type DRUG

Oxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DC-CIK

8×10\^9 autologous tumor lysate pulsed DC-CIK cells for each infusion, IV (in the vein) for four cycles, each cycle received four infusions with a 1 day interval.

Intervention Type BIOLOGICAL

Radiotherapy

45\~50 Gy in 25-28 fractions.

Intervention Type RADIATION

Chemotherapy

Oxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

FOLFOX

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18\~80 years old;
* Histologically confirmed with colorectal cancer at stage Ⅰ\~Ⅲ;
* Patients who can accept curative operations;
* Patients who have a life expectancy of at least 3 months;
* Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.

Exclusion Criteria

* Hemoglobin\<8.0 g/dL,Platelet count \<75 x 10\^9/L; ALT, AST, BUN and Cr more than normal limits on 3.0 times ;
* Known or suspected allergy to the investigational agent or any agent given in association with this trial;
* Pregnant or lactating patients;
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
* Patients who are suffering from serious autoimmune disease;
* History of organ allograft;
* Patients who had distant metastases;
* Patients who had active infection;
* Prior use of any anti-cancer treatment in 30 days;
* Now or recently will join another experimental clinical study ;
* Other situations that the researchers considered unsuitable for this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jingzhou Central Hospital

OTHER

Sponsor Role collaborator

Shenzhen Hornetcorn Bio-technology Company, LTD

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ke N Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

Jingzhou Central Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jingzhou Central Hospital Immunotherapy center

Jingzhou, Hubei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HYK-Colorectal Cancer

Identifier Type: -

Identifier Source: org_study_id